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A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219167
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: June 2006
History of Changes
  Purpose

After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks


Condition Intervention Phase
Hypertension
 Drug: aliskiren
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An 8-week, Randomized, Double-blind, Parallel-group, Multicenter Study Assessing the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Patients With at Least 65 Years of Age With Essential Hypertension, Using 24-hour ABPM, With Lisinopril 10 mg as a Reference

Resource links provided by NLM:

Drug Information available for: Aliskiren
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks

Secondary Outcome Measures:
  • Change from baseline in average 24 hour diastolic ambulatory blood pressure after 8 weeks
  • Change from baseline in sitting systolic and diastolic blood pressure after 8 weeks
  • Change from baseline in daytime diastolic ambulatory blood pressure after 8 weeks
  • Change from baseline in daytime systolic ambulatory blood pressure after 8 weeks
  • Blood pressure control target of < 140/90 mmHg after 8 weeks

Enrollment: 355
Study Start Date: April 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients with at least 65 years-old
  • Patients with essential hypertension Exclusion Criteria
  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219167

Locations
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219167     History of Changes
Other Study ID Numbers: CSPP100A2324
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
hypertension
aliskiren
age

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013